Clinical trials: Vaginal Delivery, open to volunteers
Luteal Phase Insuffiency, Progesterone Delivery
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
The aim of this clinical trial is to assess safety of a new vaginal 400mg progesterone drug-device combination product in a first in human trial.
- Trial name
- FREEDOM (NCT07136922)
- Testing
- 400mg progesterone Callavid - 2hr wear, Cyclogest 400 mg, 400mg progesterone Callavid - 3hr wear
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Calla Lily Clinical Care Ltd
Pelvic Floor Dysfunction, Perineal Laceration
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in…
- Conditions
- Pelvic Floor Dysfunction, Perineal Laceration, Wound Dehiscence, Anal Incontinence
- Trial name
- PeriPROTECT (NCT07862660)
- Testing
- Perineal protection device, BabySlide, Standard manual perineal support
- Where
- Sweden
- Volunteers
- 4,226 people
- Sponsor
- Region Skane
Fear of Childbirth, Primiparous Women
QR-Based Virtual Tour and Childbirth Outcomes
Childbirth is a unique experience that affects maternal health physiologically, emotionally, and socially, and represents a crucial step in the transition to motherhood.
- Conditions
- Fear of Childbirth, Primiparous Women, Vaginal Birth Rate, Childbirth Readiness
- Trial name
- VIRTU-BIRTH (NCT07496879)
- Testing
- Virtual Delivery Room Tour via QR Codes
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ataturk University
Pregnancy, Fear of Childbirth
Midwife-Led Antenatal Perineal Massage Education in Primiparous Pregnant Women
This study aims to evaluate the effect of midwife-led antenatal perineal massage education on pregnancy empowerment, self-efficacy for normal birth, and fear of childbirth among primiparous pregnant women.
- Conditions
- Pregnancy, Fear of Childbirth, Antenatal Education
- Trial name
- APM-EDU (NCT07593326)
- Testing
- Midwife-Led Antenatal Perineal Massage Education
- Where
- Turkey (Türkiye)
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Atlas University
18 Years and Older, Term Pregnancy
The Effect of the World Health Organisation-Based Intrapartum Care Model on Labour Pain, Comfort, Satisfaction and Postpartum Depression
This randomized controlled trial aims to evaluate the effects of the World Health Organization-based intrapartum care model on labour pain, labour comfort, childbirth satisfaction, and postpartum depression.
- Trial name
- WHO-ICARE Tria (NCT07451691)
- Testing
- WHO-ICARE Trial
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Perineal Trauma, Postpartum Pain
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal tears and episiotomies are common after vaginal birth and may cause persistent pain, impaired wound healing, pain during sexual activity, and concerns about genital appearance.
- Conditions
- Perineal Trauma, Postpartum Pain, Episiotomy, Perineal Laceration
- Trial name
- RELIEVE (NCT07727213)
- Testing
- Autologous Non-Activated Platelet-Rich Plasma, Saline (0.9%, sterile, for infusion)
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Hospital, Geneva
Vaginal Dysbiosis
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 45 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis).
- Trial name
- NCT07453069
- Testing
- FB-301, Chlorhexidine (0.5%) Vaginal Cleanse
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Freya Biosciences ApS
Pregnancy, Prematurity
Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes
The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT). Secondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across…
- Conditions
- Pregnancy, Prematurity, PPROM
- Trial name
- PROB-PROM (NCT06965049)
- Testing
- Probiotic
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Cesarean Section
Health Education to Reduce Unnecessary Cesarean Section Among Primigravida Women
This study aims to evaluate the Effectiveness of Health Educational Program for Primigravida Women in Reducing the Rate of Unnecessary Cesarean Section. Specific objectives: 1.
- Trial name
- CS (NCT07810751)
- Testing
- Health Educational Program on Modes of Delivery.
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Assiut University
Delivery Complication, Labor Long
Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the…
- Conditions
- Delivery Complication, Labor Long, Pregnancy Related
- Trial name
- soliso-2 (NCT05080309)
- Testing
- carbohydrate oral intake, free water only
- Where
- France
- Volunteers
- 600 people
- Sponsor
- University Hospital, Caen
Forceps Delivery Affecting Fetus or Newborn, Ventouse Extraction;Liveborn
Learning Curves of Different Devices for Vaginal Birth on Mannequin
Learning curves for residents and specialists for devices applied on operative vaginal birth on mannequin (Odòn, Kiwi, Simpson forceps)
- Conditions
- Forceps Delivery Affecting Fetus or Newborn, Ventouse Extraction;Liveborn, Birth; Forced
- Trial name
- NCT06923319
- Testing
- Odòn, Kiwi, Simpson skills
- Where
- 2 sites in Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- G. d'Annunzio University
Post Partum Hemorrhage
A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
This research project aims to enhance the safety of childbirth by using advanced computer models to predict the risk of postpartum hemorrhage (PPH). PPH is a significant concern for mothers during and after delivery.
- Trial name
- NCT06513351
- Testing
- Novel PPH Risk Prediction Model - Comparator Arm B
- Where
- United States
- Volunteers
- 12,500 people
- Sponsor
- Holly Ende
Early-phase Safety and PK Study of a Vaginal Gel
FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL
The goal of this clinical trial is to assess the safety and pharmacokinetics of YASO GEL in healthy adult participants. This is a first-in-human study designed to understand how the gel is absorbed and distributed in plasma and…
- Trial name
- PPCM-01 (NCT07281404)
- Testing
- YASO GEL
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Yaso Therapeutics Corporation
Induced; Birth
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
This randomized controlled trial will compare two methods of induction of labour in women with term pregnancy: concurrent use of a Foley catheter and PGE2 vaginal pessary versus sequential use of the two methods.
- Trial name
- NCT07821099
- Testing
- Foley Catheter, PGE2 Vaginal Pessary
- Where
- Pakistan
- Volunteers
- 128 people
- Sponsor
- Khyber Medical University Peshawar
Infertility
MIcronized PROgesterone in Frozen Embryo Transfer Cycles
This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP.
- Trial name
- MI-PROF (NCT05899010)
- Testing
- Vaginal progesterone 600mg daily, Vaginal progesterone 800mg daily
- Where
- Spain
- Volunteers
- 1,020 people
- Sponsor
- Fundación Santiago Dexeus Font
Cesarean Birth
The Cesarean Study: Optimizing Cesarean Sections and Improving Patient-Healthcare Provider Trust Using Evidence Informed Recommendations
Cesarean section (CS) rates have rapidly increased worldwide, with projections suggesting that by 2030, one in every three births will be by CS (1).
- Trial name
- CS (NCT07759622)
- Testing
- Cesarean Bundle
- Where
- Sweden
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Lund University
Sphincter (Anal); Perineal Rupture, Obstetric
Digital Rectal Examination vs Machine Learning-assisted Electrical Impedance Spectroscopy for Obstetric Anal Sphincter Injuries' Detection: a Prospective Cohort Study in Primiparous Women Giving Vaginal Childbirth
The investigator will evaluate the detection rate for Obstetric Anal Sphincter Injuries (OASI) in primiparas having given vaginal childbirth, comparing the sensitivity of methods available in a labour ward setting for rapid…
- Trial name
- NCT07474012
- Testing
- Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and an examination with machine learning-assisted electrical impedance spectroscopy
- Volunteers
- 110 people
- Sponsor
- IRCCS San Raffaele
Post Partum Hemorrhage
Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant…
- Trial name
- NCT06968481
- Testing
- Oxytocin sublingual, Oxytocin IM
- Where
- Nigeria
- Volunteers
- 330 people
- Sponsor
- Insud Pharma
Frozen Embryo Transfer (FET), Infertility
Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer
The goal of this observational study is to compare two commonly used vaginal progesterone formulations - soft capsules versus pessaries - in women undergoing frozen embryo transfer (FET).
- Conditions
- Frozen Embryo Transfer (FET), Infertility, Artificial Cycle, Natural Cycle
- Trial name
- COPS (NCT07461909)
- Testing
- Vaginal progesterone soft capsules, Vaginal progesterone pessaries
- Where
- Portugal
- Volunteers
- 400 people
- Sponsor
- Instituto Valenciano de Infertilidade de Lisboa
Perineal Trauma
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
This is a single-center, prospective, non-randomized post-market clinical follow-up study evaluating the implementation and clinical performance of ASISU during routine vaginal childbirth.
- Trial name
- ASISU-PMCF (NCT07844005)
- Testing
- Perineal protection device
- Where
- Denmark
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- oasicare ApS